Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy

November 10, 2023 updated by: Centre Hospitalier Universitaire de Nice

Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable results in causing tumor regression while preserving the eye. Optic neuropathy has emerged consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No neuroprotective strategies are available at present.

Citicoline is a choline agent precursor available as a dietary supplement. Citicoline conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models. In ophthalmology, citicoline has demonstrated a significant action in improving retinal and cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic neuropathy). Citicoline also exhibits a very low toxicity profile in humans.

The purpose of the study is to demonstrate whether daily oral administration of citicoline in patients treated for uveal melanomas with proton beam therapy, prevents or delays the occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual evoked potentials are measured. The tolerability/safety of the product is also evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Chu de Nice
      • Nice, France, 06000
        • Ophtalmology Departement, St Roch Hopital, Nice University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • over 18 years old
  • uveal melanoma with posterior marge located at less than 3 mm of optic papilla
  • uveal melanoma treated with proton beam therapy with irradiation of optic head nerve
  • visual acuity before proton beam therapy over 30 letters (with ETDRS test)

Exclusion Criteria:

  • antecedent of acute glaucoma with angle enclosure
  • antecedent of chronical glaucoma with angle aperture
  • antecedent of optic neuropathy optique of congenital, ischemic, inflammatory or other origins
  • antecedent of neovascular glaucoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CITICOLINE
Daily oral administration of 800 mg citicoline
Dietary supplement: CITICOLINE

Oral administration of CITICOLINE:

Form: Powder for solution Dosage: 800mg per day duration: 5 years
Placebo Comparator: Placebo
Daily oral administration of placebo
Dietary supplement: PLACEBO

Oral administration of placebo:

Form: Powder for solution duration: 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence and delay of occurrence of radiation optic neuropathy
Time Frame: Every 6 months
Occurrence and delay of occurrence of radiation optic neuropathy in patients treated for uveal melanomas with proton beam therapy
Every 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual function assessment
Time Frame: Every 6 months
Best corrected visual acuity (ETDRS) ; Pattern ERG ; Visual Evoked potentials; adverse events
Every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Collaborators

DENSMORE pharmaceuticals

Investigators

  • Principal Investigator: Stéphanie BAILLIF-GOSTOLI, MD, ophtalmology department, Nice University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2012

Primary Completion (Actual)

June 29, 2017

Study Completion (Actual)

June 29, 2017

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimated)

April 19, 2011

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-PP-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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